Johnson & Johnson Careers
Senior Associate Scientist, Bioassay Method Development (1 of 2)
Requisition ID: 2587180921
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Senior Associate Scientist, to be located in Malvern, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Within Janssen Research & Development, the Product Development & Manufacturing Science (PDMS) organization is responsible for the development, clinical supply, marketed product support, and technical life cycle management of chemical and biologic pharmaceutical products, in partnership with the Janssen Supply Group. Within PDMS, the Analytical Development group supports method development and validation, release and stability testing, technical transfer to manufacturing sites, and preparation of regulatory filings. Bioassays are specifically required for biologic pharmaceutical products.
The Senior Associate Scientist, Bioassay Methods Development will assist in the development of cell-based bioassay and binding assays to be used in support of structure-function and biological characterization studies, to better understand mechanism of action for new molecular entities in clinical development and for commercial products and as QC potency assays. The individual will be responsible for evaluation of new technologies method development, qualification, validation and transfer activities. Additional responsibilities include but are not limited to:
- Assay development, writing protocols, reports, and performing and coordinating testing to support analytical development, manufacturing process development, process validations, and manufacturing investigations across functional groups
- Accurate capture of data in a timely manner, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements is expected and the successful candidate will ensure data integrity and protocol compliance
- Maintain laboratory notebooks and prepare written protocols and reports in a GMP compliant manner
- Writing analytical sections of regulatory submissions is expected and the successful candidate will support regulatory filings including INDs and BLAs
- Providing technical support with development and QC laboratories is expected and the successful candidate will also support Quality Assurance, Regulatory Affairs and Process Development groups for all phases of product development as well as ongoing support of analytical methods for marketed products
- Bachelor's degree in Biology, Chemistry, Pharmacology or other relevant scientific field, with at least 4 years of industry experience OR a Master's degree with at least 2 years of industry experience or with relevant academic experience is required
- Experience in performing bioassays, binding assays and/or immunochemical techniques, such as flow cytometry and immunoassays is required
- Experience with method development in a variety of cell-based bioassays and binding assays is required.
- Preferred skills would include method robustness, DoE, method design and familiarity with assay validation parameters
- Experience with therapeutic proteins, including antibodies, cell and gene therapy and/or vaccines is preferred
Janssen Research & Development, LLC. (6084)